OMEGA, a Randomized, Placebo-Controlled Trial to Test the Effect of Highly Purified Omega-3 Fatty Acids on Top of Modern Guideline-Adjusted Therapy After Myocardial Infarction
OMEGA, a Randomized, Placebo-Controlled Trial to Test the Effect of Highly Purified Omega-3 Fatty Acids on Top of Modern Guideline-Adjusted Therapy After Myocardial Infarction
复制标题
DOI：
10.1161/circulationaha.110.948562
复制
发表时间：
2010-11-23
期刊：
影响因子：
37.8
通讯作者：
Senges, Jochen
中科院分区：
文献类型：
--
作者：
Rauch, Bernhard;Schiele, Rudolf;Senges, Jochen
背景：除了目前的指南调整治疗外，没有随机、双盲试验来测试高纯度omega-3脂肪酸对急性心肌梗死患者预后的影响。方法和结果-omega是一项随机、安慰剂对照、双盲、多中心试验，测试omega-3-酸乙酯-90(1g/d，为期1年)对急性心肌梗死幸存者心脏性猝死率的影响。次要终点是总死亡率和非致命性临床事件。从2003年10月到2007年6月，104个德国中心的患者(n=3851；女性，25.6%；平均年龄，64.0岁)在急性心肌梗死后3-14天被随机分组。93.8%的患者接受了急性冠状动脉造影术，77.8%的患者接受了急性经皮冠状动脉介入治疗。随访365天，事件发生率：心源性猝死分别为1.5%和1.5%(P=0.84)，总死亡率分别为4.6%和3.7%(P=0.18)，主要不良心脑血管事件分别为10.4%和8.8%(P=0.1)；存活患者分别为27.6%和29.1%(P=0.34)。结论指南调整治疗急性心肌梗死患者1年内心脏性猝死和其他临床事件的发生率较低，但omega-3脂肪酸的应用并不能进一步降低这一发生率。
Background-There is no randomized, double-blind trial testing the prognostic effect of highly purified omega-3 fatty acids in addition to current guideline-adjusted treatment of acute myocardial infarction.Methods and Results-OMEGA is a randomized, placebo-controlled, double-blind, multicenter trial testing the effects of omega-3-acid ethyl esters-90 (1 g/d for 1 year) on the rate of sudden cardiac death in survivors of acute myocardial infarction, if given in addition to current guideline-adjusted treatment. Secondary end points were total mortality and nonfatal clinical events. Patients (n=3851; female, 25.6%; mean age, 64.0 years) were randomized in 104 German centers 3 to 14 days after acute myocardial infarction from October 2003 until June 2007. Acute coronary angiography was performed in 93.8% and acute percutaneous coronary intervention in 77.8% of all patients. During a follow-up of 365 days, the event rates were (omega and control groups) as follows: sudden cardiac death, 1.5% and 1.5% (P=0.84); total mortality, 4.6% and 3.7% (P=0.18); major adverse cerebrovascular and cardiovascular events, 10.4% and 8.8% (P=0.1); and revascularization in survivors, 27.6% and 29.1% (P=0.34).Conclusions-Guideline-adjusted treatment of acute myocardial infarction results in a low rate of sudden cardiac death and other clinical events within 1 year of follow-up, which could not be shown to be further reduced by the application of omega-3 fatty acids.